LaVoieHealthScience Client Spotlight:
CO.DON CEO, Ralf Jakobs — Advancing Autologous Human Cell Transplants
Can you provide a brief overview of CO.DON and its focus?
CO.DON is focused on the development, production and marketing of cell-based products for joint-preserving, regenerative treatment of articular cartilage defects. That’s all we do and where we have built our reputation as “Human Cell Experts” – especially in Europe. CO.DON has been operating in regenerative medicine for more than 25 years, making us a very experienced manufacturer of cell transplants. Our unique, minimally invasive, 100% autologous chondrocyte transplantation cell therapy allows for treatment of cartilage damage in the knee joint using a patient’s own cells.
CO.DON’s main product treats knee cartilage defects for adults experiencing pain and mobility problems. This three-dimensional (3D) chondrocyte product received central EU marketing authorization from the European Commission, based on the assessment by the European Medicines Agency (EMA). In fact, CO.DON’s product is the only EU authorized cell-based pharmaceutical product for the regenerative treatment of cartilage defects of the knee. It is now available in Germany, the Netherlands, England and Austria and will soon be in Switzerland. We are also eyeing geographic expansion, including into North America.
In layman’s terms, please describe CO.DON’s approach to cartilage repair treatment?
CO.DON’s 100% autologous cartilage repair treatment epitomizes “personalized medicine.” Its method, matrix-associated autologous cartilage cell transplantation (M-ACT), starts with taking a small piece of cartilage from the patient’s knee using arthroscopy. The cartilage cells are then sent to CO.DON where, over a period of seven weeks, the chondrocytes — the cells in healthy cartilage that give it its structure — are isolated and multiplied in our state-of-the-art production facility. The chondrocytes naturally adhere together to form spheroids (spherical pearls), which are then placed into the damaged area of the patient’s cartilage where they adhere naturally within 20 minutes to start the cartilage regeneration process. The new tissue combines with the remaining healthy cartilage. Arthroscopic examinations after the M-ACT procedure have shown good filling of the defect with hyaline-like cartilage and seamless integration with the native cartilage.
What is the benefit of autologous cell treatment and what makes CO.DON unique?
Our biggest differentiator is our personalized medicine approach. The treatment is generated from the patient’s own cells, and is free from animal, synthetic and allogenic products so the risk of rejection is low. The procedure is minimally invasive and our product is the only EU authorized cell-based pharmaceutical product for the regenerative treatment of knee cartilage defects that is indicated for patients 55 years and older. Usually, cartilage repair treatments are only indicated for patients aged 18 – 55.
CO.DON is proud to report that more than 14,500 procedures have been performed to date in over 200 clinics using our technology. Our EU marketing authorization provides a “first mover” competitive advantage – success we feel can be replicated in North America and other geographies.
Tell us about your new Leipzig production facility – what is unique about it?
Our new production facility in Bio City, Leipzig is one of the world’s largest, most modern and unique facilities for the industrial-scale production of autologous human cell transplants.
Based on CO.DON’s proprietary Integrated Isolator Technology (IIT®), a system combining the isolator with mobile incubator systems was developed. This unique technology ensures class A conditions throughout the whole process, in that patients’ chondrocytes maintain absolute purity and sterility prior to transplant and minimizes the potential for cross contamination – without the use of antibiotics and fungistatic agents and without genetic modifications. In addition, the modular design of the cleanroom production facility is readily expandable and easily transferable to other locations/geographies. Our facility, which formally opened on October 19, 2019, is staffed by qualified pharmaceutical technicians and technical assistants in the fields of biotechnology, medicine and biology. It includes a state-of-the art cleanroom with isolators to prepare cells and mobile incubators to grow cells, as well as advanced robotics supporting production. You can see for yourself, by viewing this video.
What do you see as your growth objectives and biggest market opportunities?
Our broader plans for the future include a more widespread application of our current products, as well as expansion to new indication areas. For example, we are looking into initiating new studies on the application of our product to the hip, shoulder and ankle.
Bringing the CO.DON technology into clinical development in the United States is a key priority for us. Approximately 6 million people visit the doctor per year with articular cartilage damage to the knee, according to UCSF Health. And the overall prevalence of knee articular cartilage lesions in professional athletes is estimated to be 36 percent. Participation in sports continues to rise worldwide, which increases incidents of injuries in athletes and other active adults, and in turn, propels demand for cartilage repair products. The sports medicine market is a primary focus for CO.DON. In this video, you can see Christopher Fischer, a player in the German ice hockey league, received this career-saving treatment.
In addition, treatment of articular cartilage injury is a critical need of the Armed Forces and the Veteran population. Articular cartilage injuries leave soldiers susceptible to osteoarthritis (OA). In the U.S., the rate of OA in the general population is 12.4 per 1,000 people. In contrast, the OA rate in the U.S. military population is 26.9 per 1,000 military persons, which is more than twice that of the general population, according to research by Tulane University.